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Evaluation of Residual Urine After Intermittent Catheterisation

Evaluation of Residual Urine After Intermittent Catheterisation - Comparison of 2 Hydrophilic Coated, Intermittent Catheters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00324233
Enrollment
36
Registered
2006-05-10
Start date
2006-04-30
Completion date
2006-06-30
Last updated
2013-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Residual urine, Hematuria, Ultra sound

Brief summary

Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Interventions

DEVICEIntermittent catheter

SpeediCath catherter (SC) for intermittent catherisation

DEVICECompact intermittent catheter

SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

Sponsors

Coloplast A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male * 18 years and above * A negative urine dip-stick * Have signed informed written consent to participate

Exclusion criteria

* The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract

Design outcomes

Primary

MeasureTime frame
Residual Urine Measured by Ultra Sound2

Secondary

MeasureTime frame
Subjectively Measured Handling—
Subjectively Measured Insertion of the Catheter—

Countries

Denmark

Participant flow

Participants by arm

ArmCount
SC Then SCCM
SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
18
SCCM Then SC
SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
18
Total36

Withdrawals & dropouts

PeriodReasonFG000FG001
First Periodunable to insert catheter10
Second PeriodProtocol Violation46
Second Periodunable to insert catheter11

Baseline characteristics

CharacteristicSCCM Then SCSC Then SCCMTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
18 Participants18 Participants36 Participants
Age Continuous23.9 years
STANDARD_DEVIATION 2.9
23.6 years
STANDARD_DEVIATION 3
23.7 years
STANDARD_DEVIATION 2.9
Region of Enrollment
Denmark
18 participants18 participants36 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
18 Participants18 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 180 / 18
serious
Total, serious adverse events
0 / 180 / 18

Outcome results

Primary

Residual Urine Measured by Ultra Sound

Time frame: 2

ArmMeasureValue (MEAN)Dispersion
SpeediCathResidual Urine Measured by Ultra Sound11 mlStandard Deviation 30
SpediCath Compact MaleResidual Urine Measured by Ultra Sound6 mlStandard Deviation 23
p-value: 0.56equivalence testing
Secondary

Subjectively Measured Handling

Secondary

Subjectively Measured Insertion of the Catheter

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026